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Office of Research & Regulatory Affairs (IRB)

The mission of Cook County Health’s Institutional Review Board (IRB) is to protect human participants involved in research conducted by or through Cook County Health and to ensure all research is conducted in accordance with ethical principles and all applicable regulations.

The IRB serves as the Board of Record for all Cook County Health affiliates.  
The Office of Research & Regulatory Affairs provides: administrative support to the IRB; review process for all protocol applications; feedback to investigator; correspondence with investigators; educational programs and audits.  
Federal Wide Assurance (FWA) 
Cook County Health IRB has filed a Federal Wide Assurance (FWA) with the Department of Health and Human Services (DHHS), in which we promise to uphold federal regulations and ethical principles for human participants in research conducted by employees, agents and affiliates of Cook County Health. 
FWA number: FWA00001802 
IRB Registration Information Letter (IORG) 
The Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) require IRBs to register through a system maintained by DHHS. 
IRB Organization (IORG) number: IORG0000119 
Compliance Letter 2020
IRB Meeting Calendar 2020
Roster for IRB
Guidance for Reopening Research at Cook County Health – June 17, 2020

Guide for Investigators

The Guide for Investigators is an effort to describe expectations and provide some operational guidance for the ethical conduct of research done at all affiliates of Cook County Health. Our guide is currently under revision. As new sections are completed, they will be posted here.
Guide for Investigators – Under Revision 

IRB Manager

IRB Manager, our web-based submission system, allows users to enter protocols and protocol related information such as: new submissions, progress reports, adverse events, attachments, comments and more. Investigators have access to see the protocols they’re investigating as well as attachments, events and documents generated for their study. 

https://cchhs.my.irbmanager.com/Login.aspx
User Manual 
Quick Sheet 

Please email CCHHSIRB@cookcountyhhs.org  at the Office of Research & Regulatory Affairs to obtain a login and password. If you need assistance or would like to schedule a training session, please send an email to the address above.

Templates & Forms

Templates
Short Forms
Forms 
Chief Medical Officer

Dr. Fegan is a leading expert on healthcare policy and healthcare reform with extensive hands-on medical experience in the ever-changing arena of healthcare policy and, as a result, moves Cook County Health forward as an innovative and forward-thinking healthcare leader. She has testified before congressional committees and lectured extensively to both medical and public audiences on healthcare reform in the U.S. and Canada. Dr. Fegan serves as president of the board of directors for the Chicago-based Health & Medicine Policy Research Group. An internist, Dr. Fegan also sees patients at Cook County Health’s Woodlawn Health Center.

Chief Nursing Officer

Beena Peters joined Cook County Health after nearly three decades at the University of Illinois Hospital and Health Sciences System in Chicago, where she has served in various nursing roles since 1991. She was most recently the associate chief nursing officer, with administrative responsibility for Women, Children and Psychiatric Services. Ms. Peters earned her master’s degree in nursing and a doctorate of nursing practice. At Cook County Health she leads the nursing staff of with a focus on three key goals: nursing quality, patient experience and staff engagement. Ms. Peters is committed to building an effective and efficient workforce to deliver high-quality, patient centered care to improve the health of the people and the community through collaboration and partnership.

Division Chair, Anesthesiology and Pain Management

Dr. Torres is an anesthesiologist with additional expertise in the field of pain medicine. Dr. Torres has practiced at Cook County Health for more than 27 years and is responsible for the development and implementation of Cook County Health’s multidisciplinary Pain Management Center. Cook County Health has tracked a 36% decrease in opioid prescription volumes since 2017. Dr. Torres currently serves as system chair for Pain Management Services and leads a very successful multidisciplinary pain center which provides the latest interventional, psychologic and complementary modalities and services to our patients.

Attending Physician, Oncology Director, Hematology/Oncology Fellowship
Dr. Gupta specializes in cancer care with a specific expertise in treating lung, gynecological and gastrointestinal tumors. Her clinical interests include health care IT and hospital quality improvement. She helped study the concept of “Quick Diagnosis Units,” a model to safely work up patients on an outpatient basis rather than admitting them to a hospital, improve patient care and coordination and potentially significantly reduce health care costs.
Division Chair, Breast Oncology

Dr. Marcus is an expert in oncology who specializes in the treatment and prevention of breast cancer. She is the chair of the division of breast oncology at Cook County Health. A practiced and meticulous surgeon, Dr. Marcus has expertise in treating locally advanced breast cancer and conducting research to improve multidisciplinary treatment. She is particularly focused on underserved populations and serves as a subject matter expert on improving care delivery to minority communities as a member of the National Cancer Institute Breast Cancer Steering Committee.

Division Chair, Otolaryngology
Chair, Cook County Health Cancer Committee

As a lifelong Chicagoan, Dr. Patel’s passion for medicine dates back to childhood, when his father was a physician at Cook County Hospital. He serves patients as an expert in head and neck cancers and oncologic surgery. He is the chair of Cook County Health’s otolaryngology division and chair of the System’s Cancer Committee. Dr. Patel leads Cook County Health’s certification process from the Commission on Cancer as well as the system’s participation in national clinical trials for cancer treatment. He also holds several committee roles with the Academy of Otolaryngology and the American Head and Neck Society.

Department Chair, Correctional Health
Dr. Mennella serves at the chair and medical director for Cook County correctional health. Under her leadership, the Department of Correctional Health has been able to develop detoxification protocols and treatment plans in a centralized housing area and has increased the use of all Food and Drug Administration-approved medications for opioid use disorder. Dr. Mennella has worked with Cook County Health in furthering linkage agreements with community providers both within the ambulatory Cook County Health network and with other community partners. She was also instrumental in working with the Cook County Sherriff’s office to make naloxone training available to patients with opioid use disorder and providing these patients with a naloxone kit to prevent overdose upon release. She has lobbied for funding for mental health programs as a way to reduce crime and campaigned against the closure of Cook County mental health facilities.
Attending Physician, Emergency Medicine

As a second-generation physician at Stroger Hospital, Dr. Hedayati has devoted her career to working on the front lines of patient care, taking pride in treating all patients regardless of immigration status or ability to pay. With extensive knowledge in all areas of emergency medicine, she has a particular interest in cardiac emergencies and resuscitation, including diagnosis and management of cardiac arrest, heart attacks, abnormal cardiac rhythms, pacemakers and heart failure. She is also committed to medical education and training future generations of medical providers. Dr. Hedayati’s research projects involve emergency care, focusing on how to improve everyday practices and how physicians interface with patients.

Attending Physician, Emergency Medicine

Dr. Lu is a full-time emergency medicine attending physician at Cook County Health and a medical toxicologist with the Illinois Poison Center Toxikon Consortium. Dr. Lu’s main interests are in critical care medicine and resident and student education. She organizes the toxicology conferences for the emergency medicine residency program and has lectured nationally and internationally on various poisoning topics such as aspirin, opioids and other drugs of abuse.

Department Chair, Family and Community Medicine

Dr. Loafman, Cook County Health chair of family and community medicine, is an authority on community medicine and maternal and child health, and leads a team of 60 physicians providing comprehensive, compassionate primary and preventive care. He has dedicated much of his career to reducing health disparities in care and improving health outcomes in primary and obstetric care practices.

Senior Director, HIV Services
Dr. Adeyemi is actively involved with HIV/AIDS research, including common health problems such as co-infections, co-morbidities with HIV and hepatitis C, bone disease and long-term therapy. She was instrumental in the opening of a hepatitis C clinic at Cook County Health’s Ruth M. Rothstein CORE Center, where she has been a practicing physician for nearly two decades. Dr. Adeyemi is a member of the steering committee and co-chair of the Health Care Availability and Access Committee of Getting to Zero Illinois, a statewide initiative to end the HIV epidemic by 2030.
System Director of Healthcare Epidemiology and Infection Control
Dr. Welbel is the director of hospital epidemiology and infection control and has extensive expertise in the prevention and treatment of infectious diseases. Before joining Cook County Health in 1994, she served as a medical epidemiologist for the Centers for Disease Control and Prevention’s (CDC) division of tuberculosis elimination and an officer for epidemic intelligence services for the CDC’s Hospital Infection Program. Dr. Welbel is at the forefront of infectious diseases including influenza, Hepatitis C and tuberculosis. She is an expert on hospital infection control and preparedness and sees patients at Stroger Hospital and the Ruth M. Rothstein CORE Center.
Division Chair, Infectious Diseases
Dr. Schwartz has served as Cook County Health’s chair of infectious diseases since 2010. He has maintained the division’s excellence of caring for infections among hospitalized patients by teaching clinical infectious diseases to trainees at all levels, performing infection-related research and promoting patient safety across Cook County Health through the oversight of infection control and antimicrobial stewardship programs. Dr. Schwartz has also overseen consolidation and expansion of Cook County Health’s programs for the multidisciplinary care of Cook County residents living with HIV/AIDS.
Attending Physician, Infectious Diseases
Dr. Huhn serves as the associate director for the joint Rush University/Stroger Hospital infectious diseases fellowship program. Also, he is a medical advisor for a national HIV continuing medical education series and is a frequent teacher and lecturer across the country. His research activities include: HIV and viral hepatitis, outbreak investigations, infectious disease surveillance, and risk analysis. Dr. Huhn has published over 50 articles in peer-reviewed literature.
Chair, Department of Medicine

Dr. Mathew serves as chair of the department of medicine and directs the internal medicine services throughout Cook County Health hospitals and ambulatory sites. She also oversees the training of hundreds of residents, fellows and medical students. Dr. Mathew serves as the governor for the American College of Physicians Illinois Northern chapter as well as a member of the ACP National Board of Governors. She has a passion for the under-served and particular interest in the areas of social determinants of health and professional satisfaction. She is an awarded teacher and leader and a recognized humanitarian.

Associate Medical Director
Chairman, Department of Professional Education

Serving as the chairman of the department of professional education for Cook County Health, Dr. O’Brien is an expert in training and education programs and has been consistently recognized for his teaching abilities. He serves as a fellow of the American College of Physicians, where he oversees 25 residency and fellowship programs with more than 400 trainees. Dr. O’Brien also oversees the training of hundreds of outside rotating residents and fellows at Cook county Health. He is board certified in internal medicine and works with the American Board of Internal Medicine as a diplomat.

Regional Medical Director, Provident Hospital
and Sengstacke Health Center

Dr. Arnold Turner is medical director at Provident Hospital. He has practiced internal medicine for 35 years, primarily to underserved populations. Dr. Turner has an interest in chronic disease management. He’s previously done clinical trials on hypertension and diabetes. Dr. Turner attended Harvard Medical School.

Chief Executive Officer, CountyCare

James Kiamos is the CEO of CountyCare health plan, owned and operated by Cook County Health that serves more than 300,000 individuals in Cook County. He has more than 25 years of experience in the managed care industry and extensive experience leading hospitals and physician-hospital organizations with their managed care risk strategies and operations. He has spent considerable time in Washington, D.C. advocating for healthcare access in Cook County and Illinois.

Chief Operating Officer, Integrated Care Services

Mary Sajdak started her career with Cook County Health in 1992, when she served as the associate administrator of ambulatory care for three years and managed the day-to-day operations of Fantus Health Center. After spending nearly two decades in the private health care sector, Ms. Sajdak returned to Cook County Health, assuming the role of chief operating officer of integrated care services in 2016. Ms. Sajdak is responsible for the health system’s patient support center, inpatient and outpatient care coordination and managed care for Cook County Health.

Attending Physician, Urology

Dr. Wille is the director of kidney and stone disease for Cook County Health’s division of urology. He is the director of the Interdisciplinary Stone Clinic, a clinic with urology, nephrology and dietary resources to help prevent the forming of stones in the kidney, bladder and/or urinary tract. Dr. Wille works to help men reach their optimal health and wellness. He is dedicated to helping his patients with innovative, individualized, modern medical solutions for a variety of health concerns.

Executive Director, Behavioral Health

Diane Washington serves as the executive director of behavioral health for Cook County Health. She trained at University of Chicago Medical Center in general psychiatry and completed a fellowship in geriatric psychiatry at Rush Medical Center in Chicago. She has extensive international corporate experience in the areas of psychiatric research and development and co-morbid conditions impacting the behavioral health populations. She believes in the power of collaborative internal and external partnerships to improve access to care for all behavioral health patients.

Medical Social Worker

As a social worker at Stroger Hospital’s Trauma & Burn Department, Andrew Wheeler has helped countless patients and family member cope with the stress of traumatic incidents. He supplements the care provided by doctors and nurses to aid patients’ emotional recovery through counseling and other techniques, like meditation. He also provides support to employees after critical incidents and promotes a traumainformed workplace. A founding member of Healing Hurt People-Chicago, he coordinates connecting violently injured patients with outpatient intensive case management services to reduce re-injury and retaliation while improving overall well-being. Mr. Wheeler also advocates for awareness of post-traumatic stress in patients who have suffered severe injuries and has helped form partnerships with community organizations to address violence as a public health issue.

Division Chair, Neurology

As Cook County Health’s medical director of stroke, Dr. Warrior is an expert in treating patients with neurologic conditions including stroke, dementia, HIV-associated neurologic disease, epilepsy and headache. She leads a hospital-wide collaboration of specialists involved with the care of stroke patients. Dr. Warrior was instrumental in the creation of the Cook County Health Stroke Clinic, a once-a-week, multidisciplinary clinic with the goal of providing comprehensive care to stroke patients.

Division Chair, Ophthalmology

Ophthalmology Division Chair Dr. Thomas Patrianakos epitomizes community medicine. Born and raised in Chicago, he has been a mainstay at Cook County Health since completing his residency at Stroger Hospital in 2006 and fellowship at Harvard Medical School. He is a clinical leader in glaucoma care (including micro invasive surgery), optic nerve imaging and ophthalmology education. Dr. Patrianakos and his
team provide cutting-edge care to patients with severe eye conditions.

Optometrist

Dr. Adkins specializes in the practice of comprehensive optometry. With more than 25 years of experience, her clinical expertise includes the treatment of refractive conditions, medical diagnosis and management of glaucoma, diabetic retinopathy, infections, inflammation and post op surgical care. Dr. Adkins is passionate about encouraging teenage girls to pursue optometry careers through education and mentoring. She also works with multiple organizations to help girls pursue careers in optometry and other STEM related professions.

Division Chair, Emergency Medicine & Toxicology

Dr. Aks is a national expert in medical toxicology and has overseen the training of more than 1,400 residents and 700 students in Cook County Health’s medical toxicology rotation since 1990. He directs the Illinois Poison Center Toxikon Consortium, a partnership between Cook County Health, the University of Illinois at Chicago and the Illinois Poison Center that offers one of the nation’s few toxicology fellowships and trains all emergency medicine residents in the city of Chicago in toxicology. Toxikon also supports the Illinois Poison Center with additional clinical expertise on the most challenging cases of poisoning. Additionally, Dr. Aks has served as Cook County’s Representative to the Cook County/City of Chicago Opioid Task Force and co-wrote the expanding naloxone position statement for toxicology speciality societies (ACMT and AACT).

Attending Physician, Emergency Medicine & Toxicology

Dr. Mycyk, emergency medicine physician and toxicologist, is an international toxicology expert, specializing in environmental toxins like lead poisoning and novel drugs of abuse. His research focuses on using older, often forgotten medicines such as haloperidol for cyclic vomiting from drug abuse and drugs as antidotes for new medical problems, as these remedies are typically inexpensive and readily available.

Attending Physician, Family Medicine

Dr. Nowinski Konchak is a physician lead for the medication assisted treatment (MAT) collaborative at Cook County Health, where she works across departments to implement access to high quality, team-based substance use disorder care within CCH’s numerous care settings including 14 community health centers, Stroger hospital and emergency department, and with correctional health at Cook County Jail. She is also core faculty for the Preventive Medicine Residency Program at Cook County Health.

Department Chair, Oral Health
Dr. Alexander serves as Cook County Health chair of oral health. She has particular interest in hospital dentistry, HIV/AIDS care, oral oncology and oral surgery. Dr. Alexander has spearheaded the development and delivery of quality oral health care and clinical and operational programs, as well as improvement activities. She works on educating patients on the connection between good oral health and improvement in overall well-being, such as the link between an increased risk of heart disease in patients with poor oral health. Dr. Alexander focuses on quality direct patient care, developing programs to meet the needs of the community and coordinating teams to deliver programs, services and access to quality oral health care. She has committed much of her career to dental education and training future generations of dental providers.
Attending Physician, Oral & Maxillofacial Surgery Residency Program Director, Oral & Maxillofacial Surgery

Dr. Qaisi is the residency program director of the Oral & Maxillofacial Surgery Program at Cook County Health. He completes the “fibula jaw in a day” procedure, making Cook County Health one of only a handful of medical centers around the country able to perform this reconstructive technique. The technique allows patients to have a tumor removed, a new jaw constructed, and teeth implanted in the same operation. Dr. Qaisi’s clinical and research interests include the treatment of oral cavity cancers, head & neck benign and malignant pathology, salivary gland tumors, orthognathic (jaw) surgery, and microvascular free flap reconstruction (harvesting a patient’s own tissue for reconstruction). Dr. Qaisi serves on the executive council of the Illinois Society of Oral & Maxillofacial Surgeons. He is a diplomat of the American Board of Oral & Maxillofacial Surgery and a fellow of the American College of Surgeons.

Division Chair, Neonatology
Interim Department Chair, Pediatrics

Dr. Akintorin is the neonatology chair at Stroger Hospital’s Level III perinatal center. In addition to her duties as an attending physician, she also serves as the medical co-director of the Perinatal Center and interim chair of pediatrics. She has clinical expertise in the care of preterm and sick newborns. Dr. Akintorin received the Department of Pediatrics Teacher of the Year Award in 2016 as well as Excellence in Teaching Awards in 2013, 2014 and 2015.

Department Chair, Trauma and Burn
Dr. Bokhari is the chair of Stroger Hospital’s trauma & burn unit, the first comprehensive trauma unit in the  country. He specializes in abdominal closures and massive transfusions for critically injured patients. Because of the unit’s high standard of care and the volume of patients, the trauma unit was the second hospital in the country to train Navy surgeons to treat combat injuries. Dr. Bokhari seeks out ways to aid hospitals in other countries.

Division Chair, Burn Surgery
Dr. Poulakidas is the chair of the burn surgery department at Stroger Hospital. He has played a critical role in growing the unit to national prominence and earning recognition by the American Burn Association as a certified burn center. In addition to being one of the Midwest’s leading burn surgeons, he has expertise in treating severe non-healing wounds, smoke inhalation and acute carbon monoxide poisoning. Dr. Poulakidas is involved in clinical burn research involving frostbite treatment, seeking to lower the frequency of amputation and enhance tissue preservation.

Division Chair, Urology
Dr. Courtney Hollowell is the chair of urology at Cook County Health, overseeing urological services, including trauma, reconstructive surgery and cancer. Dr. Hollowell has published more than 80 peer-reviewed journal articles and book chapters and is nationally recognized as an expert in men’s health issues. Dr. Hollowell is the recipient of numerous awards, including the distinguished John D. Silbar Award from the North Central Section of the American Urologic Association in surgical innovation and the National Cancer Institute Minority Scholar in Cancer Research Award.

Newsletters & Other Links

Newsletters 
Workshop Slides 
Related Links 

Training for Human Participant Research

All persons who are to be substantively involved in human participant research at Cook County Health must be properly trained.
Research & Regulatory Affairs is excited to introduce the CITI Program for Research Ethics and Compliance Training to Cook County Health. In order to ensure the protection of our research participants, our Human Subjects Research (HSR) / IRB training will now expire every 3 years. With over 800 active users in IRBManager, online certification is necessary to keep up with best practices and law changes, standardize the educational platform across institutions for multisite studies, and ensure our researchers meet single IRB and sponsor requirements.

Researchers looking to become certified for the first time will now complete the HSR CITI modules prior to their in-person training. You must have a Cook County Health ID to attend the in-person session. Researchers who have already completed the in-person training will only have to complete the CITI modules. Researchers who have not taken the in-person training in the last 3 years are required to complete the HSR course by the end of 2019. Those that have completed the in-person training within the last 3 years will be required to renew at their 3-year expiration date.

Audits of Human Participant Research

The Office of Research & Regulatory Affairs conducts audits on research projects involving human participants.
Two types of audits are conducted: random post-approval monitoring audits and for-cause audits, which are a tool to provide insight to research related conduct at Cook County Health and achieve compliance with applicable federal regulations and laws as well as Cook County Health policies and procedures. Audits are also a vehicle for quality improvement, awareness of operations and continuing education. 
The purpose of the audit is to review and inspect the ethical conduct of human participant research, adherence to the study protocol, and adherence to what is presented to the IRB as well as to participants in the informed consent process. Audits typically involve the review and inspection of informed consent forms, HIPAA authorization forms, IRB records, training documentation and data management/documentation with an emphasis on confidentiality and privacy procedures. Please click on the link below to access a checklist to help you prepare for your audit. 
Cook County Health Audit Checklist 

Fee Schedule

The Office of Research & Regulatory Affairs charges a processing/administrative fee for the Cook County Health IRB review of all industry sponsored human participant research.
IRB review fees are not charged for non-profit sponsored studies supported by the National Institutes of Health (NIH), other government agencies, foundations, or investigator-initiated studies. A one–time fee will be charged for the review of any new industry funded studies. There will be no charge for renewals, amendments/modifications, protocol deviations, unanticipated events involving risk, or final reports. Please click on the link below to access the current fee structure. These fees are subject to review and change. 
Cook County Health Fee Structure Memo 

Program Contact

Office of Research & Regulatory Affairs
Email

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